Trial Outcomes & Findings for Effects of Malleo-Lok Stiffness on Lower Limb Mechanics (NCT NCT04806100)

Results Overview

Ground reaction force and ankle motion data were collected simultaneously using the force measurement and motion capture systems as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. The ankle motion data was plotted against the ankle moment data and the slope of the corresponding line was the resulting ankle joint stiffness (Nm/degree).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes).

Results posted on

2023-06-15

Participant Flow

All participants completed study activities in each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order.

Participant milestones

Participant milestones
Measure	Compliant, NoCDO, Stiff Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff).	Compliant, Stiff, NoCDO Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO).	NoCDO, Compliant, Stiff Participants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff).	NoCDO, Stiff, Compliant Participants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant).	Stiff, Compliant, NoCDO Participants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO).	Stiff, NoCDO, Compliant Participants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant).
Overall Study STARTED	5	5	3	2	4	1
Overall Study COMPLETED	5	5	3	2	4	1
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Malleo-Lok Stiffness on Lower Limb Mechanics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Compliant, NoCDO, Stiff n=5 Participants Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO), then while wearing a stiff device (Stiff).	Compliant, Stiff, NoCDO n=5 Participants Participants will be tested while wearing a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff), then while wearing no brace (NoCDO).	NoCDO, Compliant, Stiff n=3 Participants Participants will be tested while wearing no brace (NoCDO), then a moderate stiffness device (Compliant), then while wearing a stiff device (Stiff).	NoCDO, Stiff, Compliant n=2 Participants Participants will be tested while wearing no brace (NoCDO), then while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant).	Stiff, Compliant, NoCDO n=4 Participants Participants will be tested while wearing a stiff device (Stiff), then while wearing a moderate stiffness device (Compliant), then while wearing no brace (NoCDO).	Stiff, NoCDO, Compliant n=1 Participants Participants will be tested while wearing a stiff device (Stiff), then while wearing no brace (NoCDO), then while wearing a moderate stiffness device (Compliant).	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=8 Participants	20 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Continuous	31.0 years STANDARD_DEVIATION 10.6 • n=5 Participants	26.0 years STANDARD_DEVIATION 5.1 • n=7 Participants	28.0 years STANDARD_DEVIATION 6.9 • n=5 Participants	26.0 years STANDARD_DEVIATION 2.8 • n=4 Participants	22.5 years STANDARD_DEVIATION 2.5 • n=21 Participants	27.0 years STANDARD_DEVIATION 0.0 • n=8 Participants	26.9 years STANDARD_DEVIATION 6.5 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	11 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	9 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	18 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	13 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants

PRIMARY outcome

Timeframe: In-vivo ankle joint stiffness was measured for each condition before and after short bouts of walking (~15-20 minutes).

Population: All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order.

Ground reaction force and ankle motion data were collected simultaneously using the force measurement and motion capture systems as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order. The ankle motion data was plotted against the ankle moment data and the slope of the corresponding line was the resulting ankle joint stiffness (Nm/degree).

Outcome measures

Outcome measures
Measure	NoCDO n=20 Participants Participants will be tested while wearing no brace (NoCDO)	Compliant n=20 Participants Participants will be tested while wearing a moderate stiffness orthosis (Compliant)	Stiff n=20 Participants Participants will be tested while wearing a stiff orthosis (Stiff).
Ankle Joint Stiffness	0.62 Nm/degree Standard Deviation 0.32	0.97 Nm/degree Standard Deviation 0.34	0.98 Nm/degree Standard Deviation 0.34

PRIMARY outcome

Timeframe: Ankle joint power was measured for each condition during short bouts of walking (~15-20 minutes).

Population: All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order.

Peak ankle joint push-off power (W/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Outcome measures

Outcome measures
Measure	NoCDO n=20 Participants Participants will be tested while wearing no brace (NoCDO)	Compliant n=20 Participants Participants will be tested while wearing a moderate stiffness orthosis (Compliant)	Stiff n=20 Participants Participants will be tested while wearing a stiff orthosis (Stiff).
Ankle Joint Power	2.8 W/kg Standard Deviation 0.5	2.2 W/kg Standard Deviation 0.4	2.1 W/kg Standard Deviation 0.3

PRIMARY outcome

Timeframe: Ankle joint moment was measured for each condition during short bouts of walking (~15-20 minutes).

Population: All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order.

Peak ankle plantarflexion moment (Nm/kg) was calculated during gait and normalized to participant body weight as participants wore no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Outcome measures

Outcome measures
Measure	NoCDO n=20 Participants Participants will be tested while wearing no brace (NoCDO)	Compliant n=20 Participants Participants will be tested while wearing a moderate stiffness orthosis (Compliant)	Stiff n=20 Participants Participants will be tested while wearing a stiff orthosis (Stiff).
Ankle Joint Moment	1.4 Nm/kg Standard Deviation 0.1	1.3 Nm/kg Standard Deviation 0.1	1.3 Nm/kg Standard Deviation 0.1

SECONDARY outcome

Timeframe: Participants were asked to rate their pain after completing in-vivo ankle stiffness testing and walking trials in all conditions.

Population: All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order.

Participants were asked to rate their pain on a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Participants were asked to rate their pain after completing testing in no brace (NoCDO), a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Outcome measures

Outcome measures
Measure	NoCDO n=20 Participants Participants will be tested while wearing no brace (NoCDO)	Compliant n=20 Participants Participants will be tested while wearing a moderate stiffness orthosis (Compliant)	Stiff n=20 Participants Participants will be tested while wearing a stiff orthosis (Stiff).
Numerical Pain Rating Scale	0.1 score on a scale Standard Deviation 0.2	0.2 score on a scale Standard Deviation 0.5	0.2 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Participants were asked to rate their comfort after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions.

Population: All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order. The modified socket comfort score does not apply to walking without an orthosis, so was not assessed for the NoCDO condition.

Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the comfort of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Outcome measures

Outcome measures
Measure	NoCDO n=20 Participants Participants will be tested while wearing no brace (NoCDO)	Compliant n=20 Participants Participants will be tested while wearing a moderate stiffness orthosis (Compliant)	Stiff Participants will be tested while wearing a stiff orthosis (Stiff).
Modified Socket Comfort Score: Comfort	7.5 score on a scale Standard Deviation 1.7	8.0 score on a scale Standard Deviation 1.6	—

SECONDARY outcome

Timeframe: Participants were asked to rate the orthosis smoothness after completing in-vivo ankle stiffness testing and walking trials in Compliant and Stiff conditions.

Population: All participants completed all study activities (in-vivo ankle stiffness testing, walking, questionnaires) for each of the experimental conditions (NoCDO, Compliant, Stiff) in a randomized order. The modified socket comfort score does not apply to walking without an orthosis, so was not assessed for the NoCDO condition.

Study participants were asked to rank the smoothness of each orthosis on a scale from 0-10 where 0 = least smooth and 10 = most smooth orthosis. Participants were asked to rate the smoothness of each orthosis after completing testing in a moderate stiffness orthosis (Compliant) and a stiff orthosis (Stiff) in a randomized order.

Outcome measures

Outcome measures
Measure	NoCDO n=20 Participants Participants will be tested while wearing no brace (NoCDO)	Compliant n=20 Participants Participants will be tested while wearing a moderate stiffness orthosis (Compliant)	Stiff Participants will be tested while wearing a stiff orthosis (Stiff).
Modified Socket Comfort Score: Smoothness	7.8 score on a scale Standard Deviation 1.7	7.7 score on a scale Standard Deviation 2.0	—

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason M Wilken, PT, PhD

The University of Iowa

Phone: 319-335-6857

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place